FDA 510(k)

DNAP Electrode

Número K: K152547 · 2016-03-04

RequerenteAd-Tech Medical Instrument Corporation

Data da decisão2016-03-04

Código do produtoGZL

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DNAP Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K152547. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DNAP Electrode?

DNAP Electrode is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K152547.

When did DNAP Electrode receive FDA 510(k) clearance?

DNAP Electrode received FDA 510(k) clearance on 2016-03-04, under 510(k) number K152547.

Who is the listed applicant for DNAP Electrode?

The FDA 510(k) record lists Ad-Tech Medical Instrument Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DNAP Electrode?

The FDA product code for DNAP Electrode is GZL.

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Outros registros que listam Ad-Tech Medical Instrument Corporation como candidato(a)

K223276Parafusos de Ancore como Acessórios para Eletródes de Profundidade K223269Spencer Probe Depth Electrodes K191186Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode K181544Parafuso Anchor (como acessório dos Eletródos de Profundidade)K170442Cranial Drill Bits and Accessories K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes

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Dispositivos Relacionados (Código: GZL)

Fonte oficial

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